Annex 1 [317 KB PDF] - Path

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Needle-free intradermal delivery device questionnaire 4. Does the device comply with PQS E08/JI01.1? 4.1. Please specify which requirements have not been verified or those you anticipate will not be met by your device. 5. What is the dose (or range of doses) the device is capable of delivering (ml)? 6. Describe the method of waste disposal for the consumables. What waste stream is appropriate for consumables? 7. From what standard vial sizes is the device capable of drawing vaccines using the included accessories? Can vaccine be drawn from an ampoule? 8. State the device's power source. If the device is manually primed, describe the mechanism and force (N) required to do so. 9. What is the weight and size of the device (kg, length x width x height)? In addition, please list the packaged weight and size of requisite accessory equipment (kg, length x width x height). 2
Needle-free intradermal delivery device questionnaire 10. How much training (hours) is recommended for an operator to be able to use the device reliably? Please state the minimum level of expertise expected that a trainee have prior to learning to use the device. 11. Please list the environmental specifications for both device use and storage. 12. What is the expected lifetime of the device (number of injections)? What is the shelf life of the consumables (years)? 13. How many dry fires can be reasonably expected without a degradation of performance? 14. Describe the cleaning protocol for the device. 15. What is the dead space of the syringe (μl)? 16. Is this device also capable of other depths of delivery? Please also list your other delivery devices and their respective depths of delivery. For devices in development, please indicate expected date of availability for clinical studies and regulatory clearance. 3
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Annex 1 [317 KB PDF] - Path

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